Molecules / Morphine

Morphine API manufacturers

CAS 57-27-2 ATC N02AA01 Updated 9 July 2026
10
manufacturers with an active filing 5 of them hold a US DMF or a CEP
111
shortage records on file across 8 countries
418
finished-dose makers across 44 regulators
Showing 10 of 10 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Macfarlan Smith

United Kingdom
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one valid CEP for morphine, filing since 2024. Its 2021 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2021 · VAI
GMP recognised in
1 markets
How this listing is sourced EDQM certificate database
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02

Specgx

United States
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for morphine, filing since 1985. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
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03

Noramco

United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for morphine, filing since 1987. Its 2025 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Siegfried

Switzerland
Makes the API

Registered with SFDA (Saudi Arabia) for morphine. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
4 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
05

Saneca Pharmaceuticals

Slovakia
Makes the API

Registered with SFDA (Saudi Arabia) for morphine. Its GMP is recognised in 3 markets.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
3 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
06

Veranova Lp

United States
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for morphine, filing since 2008.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
07

S,A.L.A.R.S

Italy
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
08

Alcaliber S A

Spain
Makes the API

Registered with SFDA (Saudi Arabia) for morphine. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
09

Sanofi Chimie

France
Makes the API

Registered with SFDA (Saudi Arabia) for morphine. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
10

Pharbaco

Vietnam
Makes the APIFinished dose

Registered with DAV (Vietnam) for morphine. Its GMP is recognised in 1 market.

US DMF
None on file
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile

7 more manufacturers hold filings for morphine

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

Open the full list with a free account

Contract manufacturers (5)

Contract manufacturers make to order rather than holding their own filing for this molecule.

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators

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